Senior Investigation Specialist I

Why Patients Need You

We rely on a team of dedicated and agile members, who understand the importance and impact of their role in Pfizer’s mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need, when they need them.

What You Will Achieve
 

You will be part of a multi-disciplinary team that provides investigations leadership and support for cGMP clinical drug product manufacturing within Pharmaceutical Research & Development (PHRD). Specifically, the Senior Investigations Specialist will be initiating, authoring and finalizing investigations of increasing complexity in support of the Andover Liquid Dose Manufacturing (An-LDM) Facility as well as it's support functions, as applicable.
 

You will interact consistently with colleagues at various levels within manufacturing, engineering, laboratory and quality assurance disciplines.
 

This role will reside primarily on-site in Andover, Massachusetts with some flexibility to work remotely with management discretion.

How You Will Achieve It

• Initiating, authoring, and finalizing unplanned Incidents as Event Report (ERs) or Quality Assurance Reports (QARs) in the Electronic Quality management System (eQMS) in support of An-LDM drug product manufacturing within PHRD.

• In eQMS, initiating effective corrective action/preventative action (CAPA) plans to prevent non-conformance recurrences.   This may include the creation of CAPA effectiveness checks, when needed.

• Ability to access, author, progress investigations through an electronic quality management system. This includes the ability to access and navigate other electronic systems (GDMS, LIMS, SCADA, etc.) to support authoring investigations, when needed.

• Ability to lead cross-functional meetings in support of complex investigations.  This will include utilization of Method 1, 2, and 3 tools, where applicable.

• Ability to extract and summarize investigation-related data from eQMS system. This includes creating presentations and presenting data at meetings, upon request.

• Utilizing investigation techniques to interview participants and subject matter experts internally and cross-functionally in support of getting to root and contributing causes.

• Ability to manage multiple investigations, simultaneously, while consistently meeting timelines for initiation and investigation closure.

• Ability to build relationship/partner with Pharmaceutical Sciences Operations Quality (PSOQ) ensuring investigation is conducted appropriately and timely in support of drug product disposition.

• Promptly and clearly communicating any significant issues or concerns to management.

• Lead and/or support continuous improvement efforts as needed.

Qualifications
Must-Have

• BA/BS degree with 2 to 4 years of experience in Biotech Industry. OR Master's Degree with 0 to 2 years of experience

• Demonstrated experience authoring moderately complex to complex investigations within the biotech industry.  This includes prior training on formal investigation techniques/processes such as method 1, 2, or 3 and DMAIC.

• Excellent oral/written communication skills.  Ability to respond to communications promptly and clearly. 

• Proficient in eQMS or other, GMP electronic tools used for authoring investigations.

• Colleague to be self-directed/work independently to meet timelines for more than 1 investigation at a time. 

• Ability to interview, understand and learn concepts that can be translated to writing.

• Ability to flex and quickly adapt to changing environments and competing priorities.

Nice-To-Have

• Understanding of regulations as it relates to sterile drug product manufacturing.

• Navigation of Documentum based documentation system like GDMS

• Familiarity with manufacturing control and LIMS systems

PHYSICAL/MENTAL REQUIREMENTS

• Sitting or standing in Pfizer office environment with computer. Walking or bending while moving throughout Pfizer Andover Campus, when needed.

• Ability to work in a dynamic multi-discipline organizational model.

• Ability to focus in an open concept work environment

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Standard Monday-Friday work schedule. Adherence to all site and department safety
  guidelines applicable to role. Travel is not required.

• Adher